5789-cvs

5789-cvs
SPL v3
SPL
SPL Set ID e338deef-efad-1d82-e053-2995a90a1bf9
Route
ORAL
Published
Effective Date 2023-02-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ephedrine (25 mg)
Inactive Ingredients
Titanium Dioxide Sodium Starch Glycolate Type A Potato Magnesium Stearate Microcrystalline Cellulose Dibasic Calcium Phosphate Dihydrate Talc Silicon Dioxide Hypromelloses Medium-chain Triglycerides Polydextrose

Identifiers & Packaging

Pill Appearance
Imprint: 57;89 Shape: oval Color: white Size: 15 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-12-28

Description

Active ingredient (in each caplet) Ephedrine Sulfate 25 mg


Medication Information

Warnings and Precautions

Asthma alert: Because asthma may be life threatening, see a doctor if you

 are not better in 60 minutes

 get worse

 need more than 6 caplets in 24 hours

 use more than 4 caplets in 24 hours for 3 or more days a week

 have more than 2 asthma attacks in a week

These may be signs that your asthma is getting worse.

 This product will not give you asthma relief as quickly as an inhaled bronchodilator.

Description

Active ingredient (in each caplet) Ephedrine Sulfate 25 mg

Use

 for temporary relief of mild symptoms of intermittent asthma:  wheezing  tightness of chest  shortness of breath

Section 34088-5

In case of overdose, get medical help or contact a Poison Control Center right away.

Section 42229-5

* This product is not manufactured or distributed by Foundation Consumer Healthcare, LLC., owner of the registered trademark

Bronkaid®.

RETAIN OUTER CARTON FOR COMPLETE PRODUCT INFORMATION

TAMPER EVIDENT: DO NOT USE IF CARTON HAS BEEN OPENED OR BLISTER UNITS ARE TORN OR BROKEN

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2022 CVS/pharmacy

CVS.com® 1-800-SHOP CVS

Product of India. Manufactured and packaged in the U.S.A. using domestic and imported ingredients.

Section 50565-1

Keep out of reach of children.

Section 50566-9

Stop use and ask a doctor if

 your asthma is getting worse (see Asthma alert)

 you have difficulty sleeping

 you have a rapid heart beat

 you have tremors, nervousness, or seizure

Section 50567-7

When using this product

 your blood pressure or heart rate may go up. This could increase your risk of heart attack or stroke, which may cause death.

 your risk of heart attack or stroke increases if you:

 have a history of high blood pressure or heart disease

 take this product more frequently or take more than the recommended dose

 avoid foods or beverages that contain caffeine

 avoid dietary supplements containing ingredients reported or claimed to have a stimulant effect

Section 50568-5

Ask a doctor or pharmacist before use if you are

 taking prescription drugs for asthma, obesity, weight control, depression, or psychiatric or emotional conditions

 taking any drug that contains phenylephrine, pseudoephedrine, ephedrine, or caffeine (such as for allergy, cough-cold, or pain)

Section 50569-3

Ask a doctor before use if you have

 ever been hospitalized for asthma

 heart disease

 high blood pressure

 diabetes

 thyroid disease

 seizures

 narrow angle glaucoma

 a psychiatric or emotional condition

 trouble urinating due to an enlarged prostate gland

Section 50570-1

Do not use

 unless a doctor said you have asthma

 if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs taken for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

 if you have ever had an allergic reaction to this product or any of its ingredients

Section 51727-6

dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, medium chain triglycerides, microcrystalline cellulose, polydextrose, silicon dioxide, sodium starch glycolate type A, talc, titanium dioxide.

Section 51945-4

Compare to the active ingredient in Bronkaid® Max*

MAXIMUM STRENGTH**

Asthma Relief

EPHEDRINE SULFATE CAPLETS, 25 mg Bronchodilator

**STRONGEST 1 CAPLET DOSE AVAILABLE WITHOUT

A PRESCRIPTION

Relieves mild, intermittent asthma

symptoms & restores free breathing

60 Caplets

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Purpose

Bronchodilator

Directions

do not take more than directed

adults and children 12

years of age and over
take 1 caplet every 4 hours as needed.

Do not take more than 6 caplets in 24

hours or as directed by a doctor.
children under 12

years of age
do not use

Drug Facts

Active ingredient (in each caplet)

Ephedrine Sulfate 25 mg

Other Information

 each caplet contains: calcium 20 mg

 store in a dry place at 15° – 30°C (59° – 86°F)

Questions Or Comments?

Call 1-800-231-4670


Structured Label Content

Use

 for temporary relief of mild symptoms of intermittent asthma:  wheezing  tightness of chest  shortness of breath

Warnings and Precautions (34071-1)

Asthma alert: Because asthma may be life threatening, see a doctor if you

 are not better in 60 minutes

 get worse

 need more than 6 caplets in 24 hours

 use more than 4 caplets in 24 hours for 3 or more days a week

 have more than 2 asthma attacks in a week

These may be signs that your asthma is getting worse.

 This product will not give you asthma relief as quickly as an inhaled bronchodilator.

Section 34088-5 (34088-5)

In case of overdose, get medical help or contact a Poison Control Center right away.

Section 42229-5 (42229-5)

* This product is not manufactured or distributed by Foundation Consumer Healthcare, LLC., owner of the registered trademark

Bronkaid®.

RETAIN OUTER CARTON FOR COMPLETE PRODUCT INFORMATION

TAMPER EVIDENT: DO NOT USE IF CARTON HAS BEEN OPENED OR BLISTER UNITS ARE TORN OR BROKEN

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2022 CVS/pharmacy

CVS.com® 1-800-SHOP CVS

Product of India. Manufactured and packaged in the U.S.A. using domestic and imported ingredients.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

 your asthma is getting worse (see Asthma alert)

 you have difficulty sleeping

 you have a rapid heart beat

 you have tremors, nervousness, or seizure

Section 50567-7 (50567-7)

When using this product

 your blood pressure or heart rate may go up. This could increase your risk of heart attack or stroke, which may cause death.

 your risk of heart attack or stroke increases if you:

 have a history of high blood pressure or heart disease

 take this product more frequently or take more than the recommended dose

 avoid foods or beverages that contain caffeine

 avoid dietary supplements containing ingredients reported or claimed to have a stimulant effect

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are

 taking prescription drugs for asthma, obesity, weight control, depression, or psychiatric or emotional conditions

 taking any drug that contains phenylephrine, pseudoephedrine, ephedrine, or caffeine (such as for allergy, cough-cold, or pain)

Section 50569-3 (50569-3)

Ask a doctor before use if you have

 ever been hospitalized for asthma

 heart disease

 high blood pressure

 diabetes

 thyroid disease

 seizures

 narrow angle glaucoma

 a psychiatric or emotional condition

 trouble urinating due to an enlarged prostate gland

Section 50570-1 (50570-1)

Do not use

 unless a doctor said you have asthma

 if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs taken for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

 if you have ever had an allergic reaction to this product or any of its ingredients

Section 51727-6 (51727-6)

dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, medium chain triglycerides, microcrystalline cellulose, polydextrose, silicon dioxide, sodium starch glycolate type A, talc, titanium dioxide.

Section 51945-4 (51945-4)

Compare to the active ingredient in Bronkaid® Max*

MAXIMUM STRENGTH**

Asthma Relief

EPHEDRINE SULFATE CAPLETS, 25 mg Bronchodilator

**STRONGEST 1 CAPLET DOSE AVAILABLE WITHOUT

A PRESCRIPTION

Relieves mild, intermittent asthma

symptoms & restores free breathing

60 Caplets

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Purpose

Bronchodilator

Directions

do not take more than directed

adults and children 12

years of age and over
take 1 caplet every 4 hours as needed.

Do not take more than 6 caplets in 24

hours or as directed by a doctor.
children under 12

years of age
do not use

Drug Facts

Active ingredient (in each caplet)

Ephedrine Sulfate 25 mg

Other Information (Other information)

 each caplet contains: calcium 20 mg

 store in a dry place at 15° – 30°C (59° – 86°F)

Questions Or Comments? (Questions or comments?)

Call 1-800-231-4670


Advanced Ingredient Data


Raw Label Data

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